Cleared Traditional

K994159 - HMP CONTROLS (TAS) RAPIDPOINT

K994159 is an FDA 510(k) clearance for HMP CONTROLS (TAS) RAPIDPOINT, manufactured by Cardiovascular Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K994159 · Cardiovascular Diagnostics, Inc. · Hematology device
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Feb 2000
Decision
68d
Days
Class 2
Risk

K994159 is an FDA 510(k) clearance for the HMP CONTROLS (TAS) RAPIDPOINT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Diagnostics, Inc. devices

FDA 510(k) Submission Details - K994159

510(k) Number K994159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date February 15, 2000
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K994159.
STA-QUALITY HBPM/LMWH KIT
K010324 · Diagnostica Stago, Inc. · Apr 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · Diagnostica Stago, Inc. · Apr 2001
THROMBOSTRATE CONTROL PLASMAS
K000679 · Pacific Hemostasis · Mar 2000
POLLER CALIBRANTS
K991439 · European Concerted Action on Anticoagulation · Dec 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · Pacific Hemostasis · Aug 1999